Deglutition DisordersNCT02003287
Comparing FEES to VFSS in Diagnosing Laryngeal Penetration and Aspiration in Infants in the NICU
A study testing VFSS and FEES in people with Deglutition Disorders, run by Baylor Research Institute at 1 site in United States.
Trial summary
The main purpose of the study is to determine whether the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) is effective in detecting laryngeal penetration and tracheal aspiration when compared with the Videofluoroscopic Swallowing Study (VFSS) in bottle-feeding infants in the NICU. Read more about this study
- Who is it for?
- Ages 37 weeks and older
- Conditions the study is for
- Deglutition Disorders
- What is being tested?
- VFSS and FEES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 37 weeks or more postmenstrual age
- Diagnosis or suspicion of laryngeal penetration and/or tracheal aspiration by neonatal therapist and/or physician
- Inpatient at Baylor University Medical Center NICU
Who cannot join
- Not medically stable enough to undergo both FEES and VFSS as determined by neonatal therapist and/or physician
- Bilateral complete cleft lip and palate
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: Determining the Efficacy of Using FEES Compared to VFSS to Diagnose Laryngeal Penetration and Aspiration in Infants in the Neonatal Intensive Care Unit (NICU)
The main purpose of the study is to determine whether the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) is effective in detecting laryngeal penetration and tracheal aspiration when compared with the Videofluoroscopic Swallowing Study (VFSS) in bottle-feeding infants in the NICU. A secondary objective is to determine whether FEES can be used to detect laryngeal penetration and tracheal aspiration in breastfeeding NICU infants.
- Conditions
- Deglutition Disorders
- Being tested
- VFSS, FEES
- Keywords
- Deglutition Disorders, Intensive Care Units, Neonatal
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VFSSOther
Videofluoroscopic Swallow Study
FEESOther
Fiberoptic Endoscopic Swallow Study
| Study group | Role | What they receive |
|---|---|---|
| FEES | Experimental | Swallowing evaluation with the Fiberoptic Endoscopic Evaluation of Swallowing Receives: Other: FEES |
| VFSS | Active comparator | Swallowing evaluation with the Videofluoroscopic Swallowing Study Receives: Other: VFSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
High sensitivity and specificity values for FEES
Measured: one year
Secondary outcomes (1)
Evidence of laryngeal penetration or tracheal aspiration during breastfeeding
Measured: at time of assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mustafa S. Suterwala, M.D., Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003287
- Sponsor's protocol ID
- 012-282
- Status last verified
- Mar 2015
- First submitted
- 3 Dec 2013
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
da Silva AP, Lubianca Neto JF, Santoro PP. Comparison between videofluoroscopy and endoscopic evaluation of swallowing for the diagnosis of dysphagia in children. Otolaryngol Head Neck Surg. 2010 Aug;143(2):204-9. doi: 10.1016/j.otohns.2010.03.027.
PubMed 20647120Leder SB, Karas DE. Fiberoptic endoscopic evaluation of swallowing in the pediatric population. Laryngoscope. 2000 Jul;110(7):1132-6. doi: 10.1097/00005537-200007000-00012.
PubMed 10892683Suterwala MS, Reynolds J, Carroll S, Sturdivant C, Armstrong ES. Using fiberoptic endoscopic evaluation of swallowing to detect laryngeal penetration and aspiration in infants in the neonatal intensive care unit. J Perinatol. 2017 Apr;37(4):404-408. doi: 10.1038/jp.2016.239. Epub 2017 Jan 5.
PubMed 28055025
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Efficacy of Using FEES Compared to VFSS to Diagnose Laryngeal Penetration and Aspiration in Infants in the Neonatal Intensive Care Unit (NICU)
- ClinicalTrials.gov ID
- NCT02003287
- Acronym / sponsor ID
- 012-282
- Conditions
- Deglutition Disorders
- Keywords
- Deglutition Disorders, Intensive Care Units, Neonatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study is to determine whether the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) is effective in detecting laryngeal penetration and tracheal aspiration when compared with the Videofluoroscopic Swallowing Study (VFSS) in bottle-feeding infants in the NICU. A secondary objective is to determine whether FEES can be used to detect laryngeal penetration and tracheal aspiration in breastfeeding NICU infants.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FEES | Experimental | Other: FEESSwallowing evaluation with the Fiberoptic Endoscopic Evaluation of Swallowing |
| VFSS | Active comparator | Other: VFSSSwallowing evaluation with the Videofluoroscopic Swallowing Study |
Who may qualify
- Ages
- 37 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 37 weeks or more postmenstrual age
- Diagnosis or suspicion of laryngeal penetration and/or tracheal aspiration by neonatal therapist and/or physician
- Inpatient at Baylor University Medical Center NICU
Key exclusion criteria (2 listed)
- Not medically stable enough to undergo both FEES and VFSS as determined by neonatal therapist and/or physician
- Bilateral complete cleft lip and palate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VFSSVideofluoroscopic Swallow Study | Other | VFSS |
| FEESFiberoptic Endoscopic Swallow Study | Other | FEES |
Primary outcome
High sensitivity and specificity values for FEES
Time frame: one year
1 secondary outcome
Evidence of laryngeal penetration or tracheal aspiration during breastfeeding
Time frame: at time of assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Background: PubMed 20647120da Silva AP, Lubianca Neto JF, Santoro PP. Comparison between videofluoroscopy and endoscopic evaluation of swallowing for the diagnosis of dysphagia in children. Otolaryngol Head Neck Surg. 2010 Aug;143(2):204-9. doi: 10.1016/j.otohns.2010.03.027.
- Background: PubMed 10892683Leder SB, Karas DE. Fiberoptic endoscopic evaluation of swallowing in the pediatric population. Laryngoscope. 2000 Jul;110(7):1132-6. doi: 10.1097/00005537-200007000-00012.
- Derived from this study: PubMed 28055025Suterwala MS, Reynolds J, Carroll S, Sturdivant C, Armstrong ES. Using fiberoptic endoscopic evaluation of swallowing to detect laryngeal penetration and aspiration in infants in the neonatal intensive care unit. J Perinatol. 2017 Apr;37(4):404-408. doi: 10.1038/jp.2016.239. Epub 2017 Jan 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa S. Suterwala, M.D. principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VFSS and FEES in people with Deglutition Disorders, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High sensitivity and specificity values for FEES (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02003287, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.